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    ER

    Ergomed

    CRO (Contract Research Organization)

    Senior PV Officer

    Pune, IndiaRemoteFull-time10–12 yrs experiencePosted 5d ago
    All Ergomed jobs

    Job description

    • Providing support to other activities undertaken by the project team on behalf of the client and the company
    • Performing activities in the scope of ICSR management unit within agreed extent and imeframe (including, but not limited to):
    • Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
    • Performing ICSR follow up
    • SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
    • Reconciliation (clinical, partners)
    • Personal data protection
    • Product Quality Complaint handling and interaction with Quality Assurance
    • Medical Information interaction
    • MedDRA and WHO coding
    • Database Outputs and Reports (including data for monthly reporting to clients)
    • Workflow & resource management
    • Mentoring and training of new and more junior employees within the department
    • Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
    • Supporting ICSR SMEs or contributing as one of ICSR SMEs
    • More senior colleague may perform tasks assigned as per SOP to more junior position
    • Performing activities in the scope of ICSR management unit within agreed extent and Timeframe
    • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager
    • Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
    • 10-12 years of work experience in pharmacovigilance
    • Excellent communication (written and verbal) skills
    • Organization skills, including attention to details and multitasking
    • Delegation skills
    • Planning and time management
    • Technical skills
    • Team working
    • English – fluent (spoken, written
    • Advanced literacy (MS Office)

    When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

    We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

    • Quality: we hold ourselves to the standard patients deserve.

    • Integrity and trust: we do the right thing, especially when it is hard.

    • Drive and passion: we care about the outcome, because someone is waiting on it.

    • Agility and responsiveness: we move quickly, because patients cannot wait.

    • Belonging: everyone is welcome, and every voice counts.

    • Collaborative partnerships: we go further by going together.

    We look forward to welcoming your application.

    Job details are sourced from the employer's original posting.

    Open job posting
    ER

    About the company

    Ergomed

    Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development. We have nourished a true international culture here at Ergomed. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives.

    View all Ergomed jobs
    Industry
    CRO (Contract Research Organization)
    Founded
    1997
    Open roles
    122

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